BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 3070742 · Received April 22, 2013

    Report

    Report Number
    1415939-2013-00178
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    March 31, 2013
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    NIG
    PMA / PMN Number
    K052000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, RELEASE TESTING DATA REVIEW, SPECIFICITY TESTING, AND A REVIEW OF LABELING. A REVIEW OF CUSTOMER COMPLAINTS RECEIVED TO-DATE DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO DISCREPANT PATIENT RESULTS WITH ARCHITECT CA19-9XR, LIST 2K91-25, LOT 18067M500. ACCURACY TESTING WAS COMPLETED USING AN INTERNAL CA19-9XR PANEL AND RETAINED KITS OF REAGENT LOT 18067M500, WHICH MET ACCEPTANCE CRITERIA. THE INVESTIGATION RESULTS SHOW THAT THERE IS NO PRODUCT DEFICIENCY AND THAT THE ARCHITECT CA 19-9XR REAGENTS ARE PERFORMING AS INTENDED. FURTHER INVESTIGATION IS NOT REQUIRED. BASED ON THE RESULTS OF THIS EVALUATION, THE ARCHITECT CA19-9XR ASSAY, LIST 2K91-25, LOT 18067M500, IS PERFORMING AS INTENDED AND NO PRODUCT DEFICIENCY OR MALFUNCTION WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE ARCHITECT ANALYZER IS GENERATING FALSELY ELEVATED CA19-9 RESULTS ON ONE PATIENT SAMPLE. TESTING WAS RUN AND GENERATED THE FOLLOWING RESULTS: 33NG/ML; 5 HOURS LATER -143 NG/ML; AND THEN 43 AND 34 NG/ML. THE SAMPLE WAS SENT TO A REFERENCE LAB WHERE THE FOLLOWING RESULTS WERE GENERATED: 47.18, 40.74, AND 40.47 NG/ML. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172007 ARCHITECT CA 19-9XR NIG ABBOTT LABORATORIES 18067M500

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR ANALYZER, LIST # 03M74-01| SERIAL # (B)(4)| ARCHITECT I2000SR ANALYZER, LIST # 03M74-01| SERIAL # (B)(4)